Method and apparatus for producing electrotherapy current waveform with ripple

ABSTRACT

The invention provides a method and circuit for forming an electrotherapy current waveform. A charge storage device located externally of a patient&#39;s body is charged, and is discharged through the patient&#39;s body through at least two discharge electrodes connected by electrical circuitry to opposite poles of the charge storage device. A continuous discharge of the charge storage device through the electrodes is controlled so as to produce at least one phase of a current waveform that includes a ripple. The ripple has a height less than one-third of the height of the peak current of the phase, and the difference between the peak current of the phase and the lowest current of the phase is less than one third of the peak current of the phase. The current waveform has a sensing pulse portion that is integral with the therapeutic discharge portion of the current waveform.

This is a continuation-in-part of U.S. patent application Ser. No.08/769,046, filed Dec. 18, 1996, the entire disclosure of which ishereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

This invention relates to electrotherapy circuits and more particularlyrelates to external defibrillators that apply defibrillation shocks to apatient's heart through electrodes placed externally on the patient'sbody or externally on the patient's heart during surgery.

Normally, electrochemical activity within a human heart causes theorgan's muscle fibers to contract and relax in a synchronized manner.This synchronized action of the heart's musculature results in theeffective pumping of blood from the ventricles to the body's vitalorgans. In the case of ventricular fibrillation (VF), however, abnormalelectrical activity within the heart causes the individual muscle fibersto contract in an unsynchronized and chaotic way. As a result of thisloss of synchronization, the heart loses its ability to effectively pumpblood.

Defibrillators produce a large current pulse that disrupts the chaoticelectrical activity of the heart associated with ventricularfibrillation and provide the heart's electrochemical system with theopportunity to re-synchronize itself. Once organized electrical activityis restored, synchronized muscle contractions usually follow, leading tothe restoration of effective cardiac pumping.

The current required for effective defibrillation is dependent upon theparticular shape of the current waveform, including its amplitude,duration, shape (i.e., sine, damped sine, square, exponential decay),and whether the current waveform has a single polarity (monophasic) orhas both positive and negative polarity (biphasic). It has beensuggested that large defibrillation currents may cause damage to cardiactissue, however.

It is known to construct an external defibrillator that can sensepatient impedance and can set the durations of the first and secondphases of a biphasic waveform as a function of the patient impedance. Anexample of such a defibrillator is described in PCT Patent PublicationNo. WO 95/05215. Fain et al., U.S. Pat. No. 5,230,336 discloses a methodof setting pulse widths of monophasic and biphasic defibrillationwaveforms based on measured patient impedance. Kerber et al., "AdvancePrediction of Transthoracic Impedance in Human Defibrillation andCardioversion: Importance of Impedance in Determining the Success ofLow-Energy Shocks," 1984, discloses a method of selecting the energy ofdefibrillation shocks based on patient impedance measured using ahigh-frequency signal.

It is also known to construct a defibrillator with a safety resistor inthe defibrillation path (PCT Patent Publication No. WO 95/05215). Beforeapplication of a defibrillation waveform to a patient, a test pulse ispassed through the safety resistor while a current sensor monitors thecurrent. If the sensed current is less than a safety thresholdrepresentative of a short circuit, the safety resistor is removed andthe defibrillation waveform is applied to the patient.

It is known, in an implantable defibrillator, to use a biphasic waveformhaving a first phase consisting of multiple truncated decayingexponentials that form a sawtooth approximation of a rectilinear shape(Kroll, U.S. Pat. No. 5,199,429). This is accomplished by charging a setof energy storage capacitors and then successively allowing individualcapacitors to discharge during the first phase, thereby creating thesawtooth pattern in the output current of the circuit. A more recentpatent, Kroll, U.S. Pat. No. 5,514,160, describes a biphasic waveform,in an implantable defibrillator, having a rectilinear-shaped first phasecreated by placing a MOSFET current limiter in the defibrillation path.This patent states that the grossly non-linear current limiter lookslike a small and declining resistance to the capacitor. Also, Schuder etal., "Transthoracic Ventricular Defibrillation in the 100 kg Calf withSymmetrical One-Cycle Bidirectional Rectangular Wave Stimuli" describesthe use of biphasic waveforms having rectilinear first and second phasesto reverse ventricular fibrillation in calves. Stroetmann et al., U.S.Pat. No. 5,350,403, discloses a waveform having a sawtooth ripple thatis formed by periodically interrupting a non-continuous discharge of acharging circuit.

SUMMARY OF THE INVENTION

The invention provides a method and circuit for forming anelectrotherapy current waveform.

According to one aspect of the invention, a charge storage devicelocated externally of a patient's body is charged, and is dischargedthrough the patient's body through at least two discharge electrodesconnected by electrical circuitry to opposite poles of the chargestorage device. A continuous discharge of the charge storage devicethrough the electrodes is controlled so as to produce at least one phaseof a current waveform that includes a ripple.

In preferred embodiments the phase of the waveform having the ripple isa substantially rectilinear positive phase of a biphasic waveform. Webelieve that the use of a waveform having a substantially rectilinearpositive phase tends to minimize the threshold of average currentrequired for effective defibrillation, and tends to avoid damaging thepatient's tissue even if the total energy applied to the patient isrelatively high.

According to another aspect of the invention, the ripple has a height(upward jump) less than one-third of the height of the peak current ofthe phase, and more preferably less than one-fourth or one-fifth of theheight of the peak current of the phase, in order to provide a lowerthreshold of average current required for effective defibrillation andminimize the possibility of damaging the patient's tissue. In certainembodiments this phase is followed by another phase of the currentwaveform having an opposite polarity and a shorter duration. We believethe duration of the phase that includes the ripple should be between 50and 70 percent (e.g., three-fifths or five-eighths) of the combinedduration of the phase that includes the ripple and the other phase.

According to other aspects of the invention, the difference between thepeak current of the phase and the lowest current of the phase is lessthan one third of the peak current of the phase, and more preferablyless than one-fourth or one-fifth of the peak current of the phase.

In preferred embodiments the control circuit controls the discharge ofthe charge storage device by controlling the resistance of a resistivecircuit connected between the charge storage device and one of theelectrodes. The resistive circuit includes a set of resistors connectedtogether in series.

In preferred embodiments the control circuit decides, based on thepatient impedance sensed during an initial sensing pulse portion of thedischarge of the charge storage device, how many (if any) resistors toinclude in the defibrillation path at the beginning of a therapeuticdischarge portion of the discharge of the charge storage device (e.g.,at the beginning of a biphasic defibrillation waveform). This may mean,depending on the sensed patient impedance, that the current level stepsup from the sensing pulse to the beginning of the biphasicdefibrillation waveform. Once the biphasic defibrillation waveformbegins, the resistors that are present in the defibrillation path aresuccessively shorted out, thereby creating a sawtooth approximation to arectilinear shape in the output current (output decays and then jumps upevery time a resistor is shorted out).

By controlling the discharge of the charge storage device based on thesensed patient impedance, it is possible to limit the difference in thepeak current that passes through a low-impedance patient as comparedwith a high-impedance patient. Thus, the current is made more constantover a range of patient impedances, and the electrotherapy circuitprovides effective defibrillation while maintaining controlled currentlevels to reduce any possibility of damage to heart, skin, and muscletissue.

The invention provides an improved, low-cost way of creating a biphasicwaveform having a rectilinear first phase. Resistors are relativelyinexpensive as compared with capacitors, and a total of N steps inresistance values can be obtained with log₂ N resistors, as opposed to Ncapacitors, simply by connecting the resistors in series in a binarysequence (1-2-4-etc.). Because resistors are used instead of capacitors,no circuitry is required to equalize voltages on capacitors uponrecharge or to prevent reversal of voltages on capacitors.

Certain embodiments include a variable resistor stage that tends tosmooth out the ripple pattern. The variable resistor stage is a circuitthat is reset to its maximum resistance value every time one of thefixed-value resistors is shorted out and then decreases to zero over thetime interval before the next resistance step reduction.

Another advantage of the invention is that the resistors in thedefibrillation path inherently protect against possible short circuits.

The impedance of a patient when a large direct current is passingthrough the patient is different from the impedance of the patient whena small current is passing through the patient or when an alternatingcurrent is passing through the patient. We believe that the currentlevel of the sensing portion should always be at least one-third, andmore preferably one-half, of the current level at the beginning of thetherapeutic discharge portion in order to ensure detection of a patientimpedance that is similar to the impedance of the patient during thetherapeutic discharge portion.

Preferably, the discharge of the charge storage device occurs withoutrecharging of the charge storage device between the sensing pulseportion and the therapeutic discharge portion of the current waveform.Thus, it is possible to apply paddles to the chest of the patient (orapply hand-held spoons directly to the patient's heart during open heartsurgery) and immediately discharge the sensing pulse and then dischargethe biphasic defibrillation waveform immediately after the sensingpulse. This is particularly important because the patient (or thepatient's heart) may move and because it is difficult for a practitionerto apply a constant force to the patient's skin (or the patient'sheart).

Numerous other features, objects, and advantages of the invention willbecome apparent from the following detailed description when read inconnection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram of a current waveform produced by a electrotherapycircuit according to the invention.

FIG. 2 is a diagram of the key elements of electrotherapy circuitaccording to the invention.

FIG. 3 is a schematic diagram of the series-connected resistor circuitshown in the electrotherapy circuit of FIG. 2.

FIG. 4 is a schematic diagram of the H-bridge circuit shown in theelectrotherapy circuit of FIG. 2.

FIG. 5 is a schematic diagram of the variable resistor shown in theelectrotherapy circuit of FIG. 2.

FIGS. 6-9 are diagrams of current waveforms produced by anelectrotherapy circuit according to the invention based on differentmeasured patient impedances.

FIG. 10 is a set of schedules of the resistance values used forgenerating the waveforms shown in FIGS. 6-10.

FIG. 11 is a table of waveform parameters for various patient impedancesin a "normal" mode of operation and a "high-energy" mode of operation ofan electrotherapy circuit according to the invention.

DETAILED DESCRIPTION

With reference to FIG. 1, in operation of an external defibrillatoraccording to the invention, the biphasic current waveform begins with aninitial "sensing pulse" 10, which has insufficient energy for performingtherapy. The sensing pulse is integral with, i.e., immediately followedby, a biphasic defibrillation waveform having sufficient energy fordefibrillating the patient's heart. The biphasic defibrillation waveformincludes a six-millisecond, generally rectilinear positive phase 12having a sawtooth ripple 14, which is in turn followed by a fourmillisecond negative phase 16 that decays exponentially until thewaveform is truncated. As used herein, the term "rectilinear" meanshaving a straight line, regardless of whether the straight line is flator slightly tilted. The current waveform decreases through a series ofsteps 18 from the end of the positive phase to the beginning of negativephase, one of the steps being at the zero crossing. Note that forpurposes of clarity this 0.1-millisecond transition is not drawn toscale in FIG. 1; if drawn to scale the duration of this transition wouldbe much shorter than shown in FIG. 1.

We believe that a biphasic defibrillation waveform having a positiverectilinear pulse of 6 milliseconds duration followed by 0.1-millisecondtransition and a 4 millisecond negative pulse having an initialamplitude equal to the final amplitude of the positive pulse is anespecially effective waveform for defibrillation. The negative pulsedoes not need to be rectilinear.

The basic circuitry for producing the biphasic waveform is shown in FIG.2. A storage capacitor 20 (115 μF) is charged to a maximum of 2200 voltsby a charging circuit 22 while relays 26 and 28 and the H-bridge areopen, and then the electric charge stored in storage capacitor 20 isallowed to pass through electrodes 21 and 23 and the body of a patient24. In particular, relay switches 17 and 19 are opened, and then relayswitches 26 and 28 are closed. Then, electronic switches 30, 32, 34, and36 of H-bridge 48 are closed to allow the electric current to passthrough the patient's body in one direction, after which electronicH-bridge switches 30, 32, 34, and 36 are opened and H-bridge switches38, 40, 42, and 44 are closed to allow the electric current to passthrough the patient's body in the opposite direction. Electronicswitches 30-44 are controlled by signals from respective opto-isolators,which are in turn controlled by signals from a microprocessor 46, oralternatively a hard-wired processor circuit. Relay switches 26, and 28,which are also controlled by microprocessor 46, isolate patient 24 fromleakage currents of bridge switches 30-44, which may be about 500micro-amps. Relay switches 26 and 28 may be relatively inexpensivebecause they do not have to "hot switch" the current pulse. They close afew milliseconds before H-bridge 48 is "fired" by closure of some of theH-bridge switches.

Electrodes 21 and 23 may be standard defibrillation electrodes havingflat surfaces that adhere to the chest of the patient, but they mayalternatively be hand-held paddles that are applied to the chest of thepatient or hand-held spoons that are applied directly to the patient'sheart during open heart surgery. Storage capacitor 20 may be a singlecapacitor or a set of series-connected or parallel-connected capacitors.

A resistive circuit 50 that includes series-connected resistors 52, 54,and 56 is provided in the current path, each of the resistors beingconnected in parallel with a shorting switch 58, 60, and 62 controlledby microprocessor 46. The resistors are of unequal value, stepped in abinary sequence to yield 2^(n) possible resistances where n is thenumber of resistors. During the initial "sensing pulse," when H-bridgeswitches 30, 32, 34, and 36 are closed, all of the resistor-shortingswitches 58, 60, and 62 are in an open state so that the current passesthrough all of the resistors in series. Current-sensing transformer 64senses the current passing through the patient 24, from whichmicroprocessor 46 determines the resistance of the patient 24.

The initial sensing pulse is integral with, i.e., immediately followedby, a biphasic defibrillation waveform, and no re-charging of storagecapacitor 20 occurs between the initial sensing pulse and the biphasicdefibrillation waveform.

If the patient resistance sensed during the initial sensing pulse islow, all of the resistor-shorting switches 58, 60, and 62 are left openat the end of the sensing pulse so that all of the resistors 52, 54, and56 remain in the current path (the resistors are then successivelyshorted out during the positive phase of the biphasic defibrillationwaveform in the manner described below in order to approximate arectilinear positive phase). Thus, the current at the beginning of thepositive first phase 12 of the biphasic defibrillation waveform is thesame as the current during sensing pulse 10. If the patient resistancesensed during the sensing pulse is high, some or all of theresistor-shorting switches 58, 60, and 62 are closed at the end of thesensing pulse, thereby shorting out some or all of the resistors. Thiscauses an upward jump in current at the end of the sensing pulse asshown in the waveform in FIG. 1.

Thus, immediately after the sensing pulse, the biphasic defibrillationwaveform has an initial discharge current that is controlled bymicroprocessor 46 based on the patient impedance sensed bycurrent-sensing transformer 64.

The current level of the sensing pulse is always at least 50 percent ofthe current level at the beginning of positive first phase 12, and thesensing pulse, like the defibrillation pulse, is of course adirect-current pulse.

By appropriately selecting the number of resistors that remain in thecurrent path, microprocessor 46 reduces (but does not eliminate) thedependence of peak discharge current on patient impedance, for a givenamount of charge stored by the charge storage device. For a patientresistance of 15 ohms the peak current is about 25 amps, whereas for apatient resistance of 125 ohms the peak current is about 12.5 amps (atypical patient impedance is about 75 ohms).

During the positive phase of the biphasic waveform some or all of theresistors 52, 54, and 56 that remain in series with the patient 24 aresuccessively shorted out. Every time one of the resistors is shortedout, an upward jump in current occurs in the waveform, thereby resultingin the sawtooth ripple shown in the waveform of FIG. 1. The ripple tendsto be greatest at the end of the rectilinear phase because the timeconstant of decay (RC) is shorter at the end of the phase than at thebeginning of the phase. Of course, if all of the resistors have alreadybeen shorted out immediately after the end of the sensing pulse, thepositive phase of the biphasic waveform simply decays exponentiallyuntil the waveform switches to the negative phase.

As is shown in FIG. 1, at the end of the positive phase, the currentwaveform decreases through a series of rapid steps from the end of thepositive phase to the beginning of negative phase, one of the stepsbeing at the zero crossing. Microprocessor 46 accomplishes this by 1)successively increasing the resistance of resistive circuit 50 in fixedincrements through manipulation of resistor-shorting switches 58, 60,and 62, then 2) opening all of the switches in H-bridge 48 to bring thecurrent waveform down to the zero crossing, then 3) reversing thepolarity of the current waveform by closing the H-bridge switches thathad previously been open in the positive phase of the current waveform,and then 4) successively decreasing the resistance of resistance circuit50 in fixed increments through manipulation of resistor-shortingswitches 58, 60, and 62 until the resistance of resistance circuit 50 isthe same as it was at the end of the positive phase.

In one embodiment a variable resistor 66 is provided in series with theother resistors 52, 54, and 56 to reduce the sawtooth ripple. Every timeone of the fixed-value resistors 52, 54, or 56 is shorted out, theresistance of variable resistor 66 automatically jumps to a high valueand then decreases until the next fixed-value resistor is shorted out.This tends, to some extent, to smooth out the height of the sawtoothripple from about 3 amps to about 0.1 to 0.2 amps, and reduces the needfor smaller increments of the fixed-value resistors (i.e., it reducesthe need for additional fixed-value resistor stages).

The rectilinear phase may exhibit a degree of tilt, either slightly up,or slightly down. This occurs because of the "graininess" of the steps,because patient impedance may change during the waveform, and because ofinherent inaccuracies of circuit elements. For example, with respect tograininess of the steps, calculations might show that, for a 50-ohmpatient, the optimal resistance required at the end of the rectilinearphase is 14 ohms, in which case we must choose between 10 or 20 ohmsbased on the available fixed-value resistors. If we choose 10 ohms, an"error" of 4 ohms would result at the end of the rectilinear phase, andthe current would rise by about 6 or 7 percent (14-10)/(50+14)! by theend of the phase. Thus, a 15 amp rectilinear pulse would rise from 15amps to 16 amps over the rectilinear phase. If it were considereddesirable to change this rise to a droop, the microprocessor couldeasily accommodate such a change. In general, we believe it is desirableto avoid tilt greater than about 20 percent in order to avoid passage ofexcessive current through the patient's body at the high end of thetilt.

The choices of capacitor (115 μF) and voltage (2200 volts) are based onthe desired current requirements and allowable droop during the negativephase. The capacitor stores the minimum energy required to meet thedelivered charge requirements (i.e., the charge required to produce thedesired current waveform having the desired duration).

The switches in the left-hand side of H-bridge 48 can be tested byclosing switches 17 and 19, opening switches 26 and 28, closing switches30 and 32, then after a short time closing switches 42 and 44, thenafter a short time opening switches 30 and 32, and then after a shorttime opening switches 42 and 44. If the switches are working properly,current-sensing transformer 64 will sense the passage of current whenall four switches are closed, and will sense no current when switches 30and 32 or switches 42 and 44 are open. Otherwise, current-sensingtransformer 64 will detect the possible presence of a short circuit oran open circuit. Similarly, the switches in the right-hand side ofH-bridge 48 can be tested by closing switches 38 and 40, then after ashort time closing switches 34 and 36, then after a short time openingswitches 38 and 40, and then after a short time opening switches 34 and36. This valuable safety test does not require current to pass throughthe patient, due to the placement of current-sensing transformer 64outside the legs of H-bridge 48.

Microprocessor 46 easily accommodates a complex environment andfunctions in harmony with various controls, interlocks, and safetyfeatures of the electrotherapy system. In addition to performing thefunctions described herein, the microprocessor may operate a stripchart, a pacer, an ecg monitor, etc. In the event that additionalresearch should show that the characteristics of current pulses shouldbe different from those described herein, the microprocessor can bere-programmed to alter the current waveforms applied to the patient. Forexample, the microprocessor could accommodate a waveform change toproduce a rising or falling rectilinear ramp voltage with time, or awaveform having a negative phase amplitude less than (or greater than)the positive phase amplitude. Of course, the storage capacitor must haveenough stored charge to support the required output.

In an alternative embodiment the negative phase of the current waveformis substantially rectilinear, rather than exponentially decaying, andthe techniques described above for providing a substantially rectilinearpositive phase would be extended to produce the substantiallyrectilinear negative phase. Such a substantially rectilinear negativephase would require the use of a higher capacitance and voltage andhigher-rated switching devices than those employed in the circuit ofFIG. 2 (for a given initial current value of the negative phase).

Referring to FIG. 3, the resistive circuit 50 of FIG. 2 includesresistors 52 (10 ohms), 54 (two 10-ohm resistors), and 56 (four 10-ohmresistors) and IGBT shorting switches 58, 60, and 62. Alternatively,other semiconductor switching devices may be used. The resistor stringis designed to switch in 10-ohm steps. This allows for a maximumresistance of 80-ohms (including the 10-ohm variable resistor), whichmakes it possible to limit patient current to 21.5 amps for a 15-ohmpatient resistance (the current pulse would be 25.6 amps in the event ofa short circuit between the electrodes).

The values of the resistors, as well as the 115 μF value of the storagecapacitor and the capacitor voltage of 2200 volts, are determined by thecurrent required to be delivered into the patient load (about 12.5-25amps) and the range of the patient load (e.g., 125 ohms-15 ohms). TheIGBT shorting switches are switched on and off by means of opto-isolatorcircuits 68, 70, and 72 controlled by the microprocessor. Referring toFIG. 4, H-bridge 48 of FIG. 2 includes IGBT switches 30-44 similarlyswitched on and off by means of opto-isolator circuits 74, 76, 78, and80 controlled by the microprocessor. Alternatively, switches 30-44 maybe other types of semiconductor switching devices. Only oneopto-isolator is provided to control each pair of switches in each armof the H-bridge.

Referring to FIG. 5, variable resistor 66 of FIG. 2 includes resistor 82connected between resistive circuit 50 and storage capacitor 20. Theeffective resistance of variable resistor 66 is controlled by thecircuitry connected in parallel with resistor 82, through which some ofthe current from storage capacitor 20 to resistive circuit 50 can pass.

In particular, whenever the microprocessor shorts out one of thefixed-value resistors in resistive circuit 50, it also shorts capacitor84. This causes transistor 86 to turn on, which pulls the gate of FET orIGBT transistor 88 to ground, thereby turning transistor 88 off. Becausetransistor 88 is turned off, all of the current from storage capacitor20 to resistive circuit 50 passes through resistor 82.

Capacitor 84 then begins to charge linearly because of the currentsource in the collector of transistor 86. This causes the voltage at thedrain/collector of transistor 88 to increase linearly, which causes thecurrent in transistor 88 to increase linearly. When the current intransistor 88 increases, the current passing through resistor 82decreases, thereby reducing the voltage across resistor 82 and thereforereducing the effective resistance of variable resistor 66.

The electrotherapy circuit can be operated in either a "normal" mode ofoperation or a "high-energy" mode of operation. These two modes ofoperation are identical when the sensed patient impedance is below 40ohms. If the sensed patient impedance is above 40 ohms, however, themicroprocessor selects an initial resistance value of theseries-connected resistors (after the sensing pulse) that depends on themode of operation. In particular, in the "high-energy" mode of operationthe microprocessor selects a lower initial resistance than in the"normal" mode of operation. Thus, more energy will be delivered to thepatient in the "high-energy" mode of operation than in the "normal" modeof operation. A practitioner may try to defibrillate in the "normal"mode, then switch to the "high-energy" mode if unsuccessful.

In the "high-energy" mode of operation of the circuit, if the sensedpatient impedance is sufficiently high (above 85 ohms) all of theresistor-shorting switches are closed after the initial "sensing pulse,"thereby shorting out all of the series-connected resistors. This causesan upward jump at the end of the "sensing pulse," after which thepositive and negative phases of the biphasic waveform both decayexponentially.

Referring to the table of FIG. 10 and the waveforms of FIGS. 6-9, whichcorrespond to certain schedules in the table of FIG. 10, themicroprocessor schedules the resistance values of the series-connectedresistors based on the measured patient impedance, in a manner such thatthe stepwise resistance decrease of the series-connected resistors overthe course of the rectilinear phase matches the decrease in voltage ofthe storage capacitor. For the sake of simplicity, the initial sensingpulse and the series of steps between the end of the positive phase andthe beginning of negative phase have been omitted from FIGS. 6-9, and itis assumed the variable resistor discussed above is not used. FIGS. 6-9are all examples of the "high-energy" mode. FIG. 6, which corresponds toSchedule 3A in FIG. 10, is based on a patient impedance of 50 ohms, inwhich case the microprocessor selects an initial series-connectedresistance of 30 ohms and a residual series-connected resistance of 0ohms at the end of the positive phase. The total energy delivered to thepatient is about 182 joules. FIG. 7, corresponding to Schedule 4A, isbased on a patient impedance of 75 ohms, an initial resistance of 10ohms, a residual resistance of 0 ohms, and an energy of 222 joules. FIG.8, corresponding to Schedule 5A, is based on a patient impedance of 100ohms, an initial resistance of 0 ohms, and a residual resistance of 0ohms, and an energy of 217 joules. FIG. 9, corresponding to Schedule 5A,is based on a patient impedance of 125 ohms, an initial resistance of 40ohms, a residual resistance of 0 ohms, and an energy of 199 joules.

FIG. 11 includes a table, corresponding to the "normal" mode ofoperation, that identifies, as a function of the patient impedance, thepositive-phase current (in amps), ripple (in amps, assuming the variableresistor is not used), tilt of the negative phase (expressed as apercentage of the initial current value of the negative phase), totaldelivered energy (in joules), and the deviation of the total deliveredenergy from the normal mode's "rating" of 150 joules. FIG. 11 alsoincludes a similar table for the "high-energy" mode of operation,identifying positive-phase current, tilt of the positive phase (based ona straight-line average through the ripples), ripple, tilt of thenegative phase, total delivered energy, and the deviation of the totaldelivered energy from the "rating" of 170 joules.

In both the high-energy and normal modes described above, the storagecapacitor is charged to its maximum voltage of 2200 volts. Other modesof operation can be developed in which the storage capacitor is chargedto a lesser voltage, or in which different resistance schedules areused.

There have been described novel and improved electrotherapy circuits andtechniques for using them. It is evident that those skilled in the artmay now make numerous uses and modifications of and departures from thespecific embodiment described herein without departing from theinventive concept. For example, the techniques described herein can beused in connection with implantable defibrillators rather than externaldefibrillators or in connection with electrotherapy circuits other thandefibrillator circuits or even circuits that perform functions otherthan electrotherapy.

What is claimed is:
 1. A method of forming an electrotherapy currentwaveform, comprising the steps of:charging a charge storage devicelocated externally of a patient's body; discharging the charge storagedevice through the patient's body through at least two dischargeelectrodes connected by electrical circuitry to opposite poles of thecharge storage device; and controlling a continuous discharge of thecharge storage device through the electrodes so as to produce at leastone phase of a current waveform that includes a ripple.
 2. The method ofclaim 1 wherein the step of discharging the charge storage devicecomprises applying the current waveform as a defibrillation pulse to apatient.
 3. The method of claim 1 wherein the step of discharging thecharge storage device comprises applying the current waveformtransthoracically to a patient.
 4. The method of claim 1 wherein theripple has a height less than one third the height of the peak currentof the phase having the ripple.
 5. The method of claim 4 wherein theripple has a height less than one fourth the height of the peak currentof the phase having the ripple.
 6. The method of claim 5 wherein theripple has a height less than one fifth the height of the peak currentof the phase having the ripple.
 7. The method of claim 1 wherein thephase that includes the ripple is followed by another phase of thecurrent waveform having a polarity opposite that of the phase thatincludes the ripple.
 8. The method of claim 1 wherein the ripple hasmore than two teeth.
 9. An electrotherapy circuit for administering to apatient a current waveform, comprising:a charge storage device; at leasttwo non-implanted discharge electrodes connected by electrical circuitryto opposite poles of the charge storage device; a control circuitconnected to the charge storage device, that controls a continuousdischarge of the charge storage device through the electrodes so as toproduce at least one phase of a current waveform that includes a ripple.10. A method of forming an electrotherapy current waveform, comprisingthe steps of:charging a charge storage device; discharging the chargestorage device through at least two discharge electrodes connected byelectrical circuitry to opposite poles of the charge storage device; andcontrolling a continuous discharge of the charge storage device throughthe electrodes so as to produce at least one phase of a current waveformthat includes a ripple with a height less than one-third the height ofthe peak current of the phase.
 11. The method of claim 10 wherein thestep of discharging the charge storage device comprises applying thecurrent waveform as a defibrillation pulse to a patient.
 12. The methodof claim 10 wherein the step of discharging the charge storage devicecomprises applying the current waveform transthoracically to a patient.13. The method of claim 10 wherein the ripple has a height less thanone-fourth the height of the peak current of the phase.
 14. The methodof claim 13 wherein the ripple has a height less than one-fifth theheight of the peak current of the phase.
 15. The method of claim 10wherein the phase that includes the ripple is followed by another phaseof the current waveform having a polarity opposite that of the phasethat includes the ripple.
 16. The method of claim 10 wherein the chargestorage device is located externally of a patient's body through whichthe charge storage device is discharged during the discharging step. 17.The method of claim 10 wherein the ripple has more than two teeth. 18.An electrotherapy circuit for administering to a patient a currentwaveform, comprising:a charge storage device; at least two dischargeelectrodes connected by electrical circuitry to opposite poles of thecharge storage device; a control circuit connected to the charge storagedevice, that controls a continuous discharge of the charge storagedevice through the electrodes so as to produce at least one phase of acurrent waveform that includes a ripple with a height less thanone-third the height of the peak current of the phase.
 19. A method offorming an electrotherapy current waveform, comprising the stepsof:charging a charge storage device; discharging the charge storagedevice through at least two discharge electrodes connected by electricalcircuitry to opposite poles of the charge storage device; andcontrolling a continuous discharge of the charge storage device throughthe electrodes so as to produce at least one phase of a current waveformthat includes a ripple wherein the difference between the peak currentof the phase and the lowest current of the phase is less than one thirdof the peak current of the phase.
 20. The method of claim 19 wherein thestep of discharging the charge storage device comprises applying thecurrent waveform as a defibrillation pulse to a patient.
 21. The methodof claim 19 wherein the step of discharging the charge storage devicecomprises applying the current waveform transthoracically to a patient.22. The method of claim 19 wherein the difference between the peakcurrent of the phase and the lowest current of the phase is less thanone-fourth of the peak current of the phase.
 23. The method of claim 22wherein the difference between the peak current of the phase and thelowest current of the phase is less than one-fifth of the peak currentof the phase.
 24. The method of claim 19 wherein the phase that includesthe ripple is followed by another phase of the current waveform having apolarity opposite that of the phase that includes the ripple.
 25. Themethod of claim 19 wherein the charge storage device is locatedexternally of a patient's body through which the charge storage deviceis discharged during the discharging step.
 26. The method of claim 19wherein the ripple has more than two teeth.
 27. An electrotherapycircuit for administering to a patient a current waveform, comprising:acharge storage device; at least two discharge electrodes connected byelectrical circuitry to opposite poles of the charge storage device; acontrol circuit connected to the charge storage device, that controls acontinuous discharge of the charge storage device through the electrodesso as to produce at least one phase of a current waveform that includesa ripple wherein the difference between the peak current of the phaseand the lowest current of the phase is less than one third of the peakcurrent of the phase.
 28. A method of forming an electrotherapy currentwaveform, comprising the steps of:charging a charge storage device;discharging the charge storage device through at least two dischargeelectrodes connected by electrical circuitry to opposite poles of thecharge storage device; and controlling a continuous discharge of thecharge storage device through the electrodes so as to produce one phaseof a current waveform wherein the difference between the peak current ofthe phase and the lowest current of the phase is less than one third ofthe peak current of the phase, followed by another phase of the currentwaveform having a polarity opposite to that of the one phase and aduration less than that of the one phase.
 29. The method of claim 28wherein the step of discharging the charge storage device comprisesapplying the current waveform as a defibrillation pulse to a patient.30. The method of claim 28 wherein the step of discharging the chargestorage device comprises applying the current waveform transthoracicallyto a patient.
 31. The method of claim 28 wherein the duration of the onephase is between fifty and seventy percent of the combined duration ofthe one phase and the other phase.
 32. The method of claim 31 whereinthe duration of the one phase is about three-fifths of the combinedduration of the one phase and the other phase.
 33. The method of claim31 wherein duration of the one phase is about five-eighths of thecombined duration of the one phase and the other phase.
 34. The methodof claim 28 wherein the charge storage device is located externally of apatient's body through which the charge storage device is dischargedduring the discharging step.
 35. The method of claim 28 wherein thedifference between the peak current of the phase and the lowest currentof the phase is less than one-fourth of the peak current of the phase.36. The method of claim 28 wherein the phase in which the differencebetween the peak current of the phase and the lowest current of thephase is less than one third of the peak current of the phase comprisesa ripple.
 37. An electrotherapy circuit for administering to a patient acurrent waveform, comprising:a charge storage device; at least twodischarge electrodes connected by electrical circuitry to opposite polesof the charge storage device; a control circuit connected to the chargestorage device, that controls a continuous discharge of the chargestorage device through the electrodes so as to produce one phase of acurrent waveform wherein the difference between the peak current of thephase and the lowest current of the phase is less than one third of thepeak current of the phase, followed by another phase of the currentwaveform having a polarity opposite to that of the one phase and aduration less than that of the one phase.
 38. A method of forming anelectrotherapy current waveform, comprising the steps of:charging acharge storage device; discharging the charge storage device through atleast two discharge electrodes connected by electrical circuitry toopposite poles of the charge storage device; and controlling acontinuous discharge of the charge storage device through the electrodesso as to produce one phase of a current waveform wherein the differencebetween the peak current of the phase and the lowest current of thephase is less than one third of the peak current of the phase, followedby another phase of the current waveform in the form of a truncatedexponential and having a polarity opposite to that of the one phase. 39.The method of claim 38 wherein the step of discharging the chargestorage device comprises applying the current waveform as adefibrillation pulse to a patient.
 40. The method of claim 38 whereinthe step of discharging the charge storage device comprises applying thecurrent waveform transthoracically to a patient.
 41. The method of claim38 wherein the charge storage device is located externally of apatient's body through which the charge storage device is dischargedduring the discharging step.
 42. The method of claim 38 wherein thedifference between the peak current of the phase and the lowest currentof the phase is less than one-fourth of the peak current of the phase.43. The method of claim 42 wherein the difference between the peakcurrent of the phase and the lowest current of the phase is less thanone-fifth of the peak current of the phase.
 44. The method of claim 38wherein the phase in which the difference between the peak current ofthe phase and the lowest current of the phase is less than one third ofthe peak current of the phase comprises a ripple.
 45. An electrotherapycircuit for administering to a patient a current waveform, comprising:acharge storage device; at least two discharge electrodes connected byelectrical circuitry to opposite poles of the charge storage device; acontrol circuit connected to the charge storage device, that controls acontinuous discharge of the charge storage device through the electrodesso as to produce one phase of a current waveform wherein the differencebetween the peak current of the phase and the lowest current of thephase is less than one third of the peak current of the phase, followedby another phase of the current waveform in the form of a truncatedexponential and having a polarity opposite to that of the one phase.